N/A GEN11Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 20705036013959), received between May 11, 2018 and Feb 26, 2026 — classified as 4 deaths, 9 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (31 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Failure to Read Input Signal

  IT WAS REPORTED BY SERVICE AND REPAIR THAT THE UNIT FAILED ELECTRICAL SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457683 ↗
• MalfunctionDec 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO THE BIOMED THAT THE UNIT WAS REPORTED AS BROKEN WITH NO DESCRIPTION. HOSPITAL BIOMED NOTICED PHYSICAL DAMAGE TO THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876279 ↗
• MalfunctionNov 21, 2025Failure to Read Input Signal; Failure to Read Input Signal

  SERVICE REQUESTED BY CUSTOMER. UNIT FAILED ELECTRICAL SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619806 ↗
• MalfunctionNov 17, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED BY SERVICE AND REPAIR THAT, SPECIAL USE DEMO REQUEST FOR LAB ENDING 9/19/202510/28/2025 - UNIT FAILED ELECTRICAL SAFETY. CONVERTED FROM PM TO CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569948 ↗
• MalfunctionOct 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT EQUIPMENT HAS A DIFFERENT SERIAL NUMBER IN THE SOFTWARE WITH THE LABEL. SOFTWARE UPGRADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427145 ↗
• MalfunctionJun 2, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED BY SERVICE AND REPAIR; THAT THE DEVICE WOULD NOT PASS ELECTRICAL SAFETY DUE TO DAMAGED BOTTOM ENCLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125510 ↗
• MalfunctionMay 12, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DEVICES FAILS ELECTRICAL SAFETY, POWER SUPPLY FAILURE IN ERROR LOG DURING PM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002678 ↗
• MalfunctionJan 31, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED BY SERVICE AND REPAIR THAT DURING EVALUATION OF THE DEVICE IN THE SERVICE CENTER IT WAS DISCOVERED THAT THE DEVICE WOULD NOT PASS GROUND BOND TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287243 ↗
• MalfunctionOct 11, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED BY SERVICE AND REPAIR THAT THE UNIT WOULD NOT PASS ELECTRICAL SAFETY. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427206 ↗
• InjurySep 25, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GENERATOR IS SHOWING PROBLEM ONLY AFTER VERY FEW CASES. IT'S RESTARTING AGAIN AND AGAIN WHICH IS CAUSING THE SURGEON TO BE UNABLE TO PERFORM SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300962 ↗
• MalfunctionApr 15, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE THE FAILS ELECTRICAL SAFETY TESTING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110521 ↗
• MalfunctionFeb 29, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED BY THE SERVICE CENTER THAT DURING EVALUATION FOUND THAT UNIT FAILED ELECTRICAL SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807789 ↗
• MalfunctionJan 11, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT WHEN RUNNING THE UNIT THROUGH AN ELECTRICAL TEST AFTER RECEIVING BACK FROM REPAIR IT WAS FOUND THAT THE UNIT FAILED THE GROUND RESISTANCE TEST, THE READING WAS HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493306 ↗
• InjuryJan 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER WAS ASKING HOW TO UPDATE GEN11, IN THE MIDDLE OF AN UNKNOWN PROCEDURE AND ENSEAL WILL NOT WORK. CUSTOMER STATED THAT THEY USED IT "RECENTLY" WITH NO ISSUES BUT TODAY IT WILL NOT WORK. ERD NURSE LET THE CUSTOMER KNOW THAT WE NEED THE SERIAL NUMBER AND/OR SOFTWARE VERSION AND ENSEAL INFORMATION IN ORDER TO ASSIST. CUSTOMER INDICATED SHE WOULD CALL BACK AS THE PROCEDURE WAS ONGOING. CUSTOMER CALLED BACK AND INDICATED THAT THEY COULD NOT COMPLETE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN IF THE GENERATOR WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 18484524 ↗
• MalfunctionDec 5, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE IN THE SERVICE CENTER THE DEVICE WAS NOT PASSING THE GROUND BOND PORTION OF ELECTRICAL SAFETY TESTING. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266990 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPY PLUS GASTRECTOMY PROCEDURE, THE FORCEPS ARE BEING USED AND THE ASSISTANT AND THE TIP BURN, WHICH CAUSES THE PATIENT TO BLEED. THE SURGERY MUST IMMEDIATELY BE CONVERTED TO OPEN AND ANOTHER ENSEAL DEVICE OPENED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18246312 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPY PLUS GASTRECTOMY PROCEDURE, THE FORCEPS ARE BEING USED AND THE ASSISTANT AND THE TIP BURN, WHICH CAUSES THE PATIENT TO BLEED. THE SURGERY MUST IMMEDIATELY BE CONVERTED TO OPEN AND ANOTHER ENSEAL DEVICE OPENED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18246280 ↗
• MalfunctionNov 8, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GENERATOR FAILS ELECTRICAL SAFETY TESTING AND POWER CABLE CONNECTOR IS LOOSE INSIDE OF THE UNIT. NO PATIENT HARM/INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094879 ↗
• MalfunctionOct 5, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A FAILURE OF THE ELECTRICAL SAFETY TEST OF THE EQUIPMENT. THERE WAS NO HARM TO THE HEALTH OF THE OPERATOR OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878444 ↗
• InjurySep 13, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT A GEN11 WAS PREPARED FOR A LAPAROSCOPIC OESOPHAGECTOMY AND IT POWERED UP PERFECTLY. A HP054 WAS CONNECTED TO THE GEN11 CORRECTLY AND CONFIRMED 45 USES REMAINING. HARH36 WAS CONNECTED TO THE HP054 CORRECTLY AND THE GEN11 THEN DISPLAYED "ACTIVATE INSTRUMENT FOR 2 SECONDS TO RUN TEST". AS SOON AS THE SGN TOUCHED ANY POWER BUTTON THE GEN11 IMMEDIATELY GAVE AN "ACTIVATION SWITCH ERROR". THE DISPLAY THEN IMMEDIATELY DISPLAYED AN ERROR AND INSTRUCTED "PRESS OK TO CONTINUE", WHICH DID NOT YIELD ANY RESULTS. SEVERAL FURTHER ATTEMPTS USING DIFFERENT POWER BUTTONS ON THE HARH36 AND CONFIRMING THE CORRECT CONNECTION STEPS SHOWED THE SAME ERROR. A 2ND BRAND NEW AND STERILE HARH36 WAS THEN CONNECTED, BUT DISPLAYED THE SAME ERROR. THE PROCEDURE WAS CONVERTED TO OPEN & THE SGN COMPLETED THE CASE USING AN OPEN LIGASURE DEVICE. THERE WERE NO FURTHER PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 17736363 ↗
• MalfunctionSep 8, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN PASSING THE CERTIFICATION PROCEDURE, THE CERTIFYING BODY REVEALED A DISCREPANCY BETWEEN THE INFORMATION REFLECTED ON THE BACK OF THE GEN11 GENERATOR AND THE INFORMATION THAT IS INDICATED ON THE LABEL ATTACHED TO THE DOSSIER OF THE MA. WE ASSUME THAT A LABEL FROM THE OLD GENERATOR WAS ATTACHED TO THE REGISTRATION DOSSIER. IT MAY BE NECESSARY TO REPLACE THE LABEL IN THE DOSSIER AND, ACCORDINGLY, MAKE CHANGES TO THE MA. WE ALSO WANT TO NOTE THAT THE NEW MA CONTAINS THE ADDRESSES OF ALL PRODUCTION SITES, BUT THE ADDRESSES OF ETHICON ENDO-SURGERY, LLC, USA ARE NOT LISTED ANYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710740 ↗
• MalfunctionSep 8, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN PASSING THE CERTIFICATION PROCEDURE, THE CERTIFYING BODY REVEALED A DISCREPANCY BETWEEN THE INFORMATION REFLECTED ON THE BACK OF THE GEN11 GENERATOR AND THE INFORMATION THAT IS INDICATED ON THE LABEL ATTACHED TO THE DOSSIER OF THE MA. WE ASSUME THAT A LABEL FROM THE OLD GENERATOR WAS ATTACHED TO THE REGISTRATION DOSSIER. IT MAY BE NECESSARY TO REPLACE THE LABEL IN THE DOSSIER AND, ACCORDINGLY, MAKE CHANGES TO THE MA. WE ALSO WANT TO NOTE THAT THE NEW MA CONTAINS THE ADDRESSES OF ALL PRODUCTION SITES, BUT THE ADDRESSES OF ETHICON ENDO-SURGERY, LLC, USA ARE NOT LISTED ANYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710700 ↗
• MalfunctionAug 17, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT THE GROUNDING CONTINUITY TEST OF POWER CORD DURING PREVENTATIVE MAINTENANCE INSPECTION CONFIRMED TO BE OUT OF SPECIFICATION. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE CUSTOMER DOES NOT WANT TO PROVIDE ADDITIONAL INFORMATION ABOUT THIS PC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564229 ↗
• MalfunctionMar 9, 2023Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, AT THE END OF A THYROID SURGERY, THE WARD NURSE WAS GOING TO MOVE THE TRANSPORTER CART OF THE GEN11 GENERATOR AND WHEN TAKING THE AC CABLE, A SHORT CIRCUIT OCCURS THAT CAUSES COMBUSTION OF THE EQUIPMENT IN THE REAR PANEL, IN ITS AC CONNECTION. THE NURSE LEAVES THE SURGICAL ROOM, STARTLED BY THE SHOCK OF SOUND AND COMBUSTION. THE ANESTHESIOLOGIST PROCEEDS TO DISCONNECT THE EQUIPMENT FROM THE ELECTRICAL OUTLET, TO INTERRUPT THE FLOW OF ELECTRICITY TO THE EQUIPMENT AND THE FLAMES STOP IMMEDIATELY. CHECKED WITH THE NURSE INVOLVED IN THE INCIDENT AND STATED THAT SHE HAD NOT SUFFERED ANY INJURY FROM THE COMBUSTION OF THE EQUIPMENT OR FROM THE PASSAGE OF AN ELECTRIC CURRENT. THE GENERATOR IS WITHDRAWN FROM THE SURGICAL SERVICE AND IS PLACED IN THE ENGINEERING AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514272 ↗
• MalfunctionFeb 9, 2023Failure to Read Input Signal; Appropriate Device Problem Term/Code Not Available; Failure to Read Input Signal; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE UNIT EMITS A BURNING SMELL AND FAILS THE ELECTRICAL SAFETY TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334529 ↗